(87 days)
Not Found
No
The device description and performance studies focus on basic temperature sensing and signal processing, with no mention of AI or ML.
No
The device is described as a temperature probe and stethoscope intended for monitoring and diagnostic purposes (measuring temperature and auscultation of heart/lung sounds), not for treating a condition or disease.
Yes
The device is described as a "temperature probe" and an "esophageal stethoscope with temperature sensor," which are used for "continuous monitoring" of "esophageal or rectal temperature as an indicator of core body temperature." The esophageal stethoscope also allows for "auscultation of the heart and lung sounds as an indicator of core body temperature and cardio-pulmonary performance." These functions of monitoring physiological parameters to indicate bodily states fall under the definition of a diagnostic device.
No
The device description explicitly states it uses "Disposable Temperature Probes using thermistors as temperature sensors" and that the "signal of the sensor is processed and displayed by the monitoring unit." This indicates the device includes physical hardware components (probes, sensors, monitoring unit) and is not solely software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body (like blood, urine, tissue) to provide information about a person's health.
- Device Function: The described devices are temperature probes and stethoscopes with temperature sensors. They are placed within the body (esophagus or rectum) to directly measure temperature and auscultate sounds. They do not analyze specimens taken from the body.
- Intended Use: The intended use is for continuous monitoring of core body temperature and cardio-pulmonary performance by direct measurement within the body.
Therefore, these devices fall under the category of in vivo (within the living body) medical devices, not in vitro diagnostics.
N/A
Intended Use / Indications for Use
Esophageal/Rectal Temperature Probe, Catalog Numbers 483M-9, 483M-12, and 491B: The CSZ sesphageal/rectal temperature probe is intended for use in routine continuous monitoring of the esophageal or medal temperature as an indicator or core body temperature. The probe is designed for placement in the esophagus or rectum.
Boohageal Stethoscope with Temperature Sensor, Catalog Numbers 493M-9, 493M-12, 493M-18, and 493M-24: The CSZ esophageal stethoscope with temperature sensor is intended for use when the esophageal caperature is continuously monitored along with the auscultation of the heart and lung sound as an indicator of core body temperature and cardio-pulmonary performance.
Product codes (comma separated list FDA assigned to the subject device)
BZT
Device Description
isposable Temperature Probes using thermistors as temperature sensors. The signal of the sensor s processed and displayed by the monitoring unit.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
esophagus or rectum
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Testing was done in accordance with BS EN 12470-4, Clinical Thermometers.
The performance testing has shown that the CSZ products included in his pre-market submission meet the requirements of EN 12470-4 for Clinical Electronic hermometers, and therefore maintain the same levels of safety and effectiveness as the predicate evice currently in commercial distribution.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 868.1920 Esophageal stethoscope with electrical conductors.
(a)
Identification. An esophageal stethoscope with electrical conductors is a device that is inserted into the esophagus to listen to a patient's heart and breath sounds and to monitor electrophysiological signals. The device may also incorporate a thermistor for temperature measurement.(b)
Classification. Class II (performance standards).
0
Image /page/0/Picture/0 description: The image shows the logo for Cincinnati Sub-Zero. The logo is black and white and features the letters "CSZ" in a stylized font. The words "Cincinnati Sub-Zero" are written below the letters in a smaller font. The logo is simple and modern.
Cincinnati Sub-Zero Products, Inc. 12011 Mosteller Road Cincinnati Ohio 45241-1528 Telephone: (513) 772-8810 FAX: (513) 772-9119 WEBSITE: http://www.cszinc.com E-MAIL: cszinc@cszinc.com
510K Summary
| 1. | Owner's Name: | Steve Berke |
|---|---|---|
| Address: | Cincinnati Sub-Zero Products, Inc. (CSZ) | |
| 12011 Mosteller Rd. | ||
| Cincinnati, OH 45241 | ||
| Phone: | 513-772-8810 | |
| Fax: | 513-772-9119 | |
| Contact: | Fatma Ali, Director of Quality & Regulatory Affairs, CSZ | |
| Organization Number: | 84901 | |
| Establishment: | New Device | |
| Registration Number: | 1516825 | |
| Operations: | Manufacturer and Specification Developer | |
| Date: | Monday, December 03, 2007 | |
| 2. | Name of the Devices: | |
| - | Esophageal/Rectal Temperature Probe, and | |
| Esophageal Stethoscope With Temperature Sensor Probe | ||
| Probes trade/proprietary name: THERMA-TEMP, STERI-PROBE | ||
| Common name: | Temperature Probe | |
| Classification: Esophageal Rectal and Esophageal Stethoscope, with Electrical Conductors | ||
| Product Code: | BZT |
Image /page/0/Picture/5 description: The image shows a logo with the text "Certified WBENC Women's Business Enterprise". The logo is enclosed in a rounded rectangle. The word "Certified" is at the top, followed by the acronym "WBENC" in a larger font, and then "Women's Business Enterprise" at the bottom.
1
Predicate Devices:
Smiths Level 1 Esophageal/Rectal Temperature Probe; and
Esophageal Stethoscope With Temperature Sensor Probe
goth devices are originally, listed under Respiratory Support Products, Inc. as referenced in 510K Sumber's: K864043 & K864044
Device Description:
isposable Temperature Probes using thermistors as temperature sensors. The signal of the sensor s processed and displayed by the monitoring unit.
Intended Use:
ontinuous measurement of core body temperature through the esophagus or the rectum.
Comparison to the Predicate Device:
he CSZ Esophageal/Rectal Probes and Esophageal Stethoscope are substantially equivalent to he Smiths Level 1 Esophageal/Rectal Probes and Esophageal Stethosoped
Discussion of Non-clinical Tests performed:
esting was done in accordance with BS EN 12470-4, Clinical Thermometers.
Conclusion:
The CSZ Esophageal/Rectal Probe and Esophageal Stethoscope have the same intended use and echnological characteristics as the cleared devices (Smiths Level 1 Esophageal/Rectal Probes and Esophageal Stethoscope). The performance testing has shown that the CSZ products included in his pre-market submission meet the requirements of EN 12470-4 for Clinical Electronic hermometers, and therefore maintain the same levels of safety and effectiveness as the predicate evice currently in commercial distribution.
certify that, in my capacity as the Director of Quality and Regulatory Affairs of Cincinnati Sub-Zero Products Inc., I believe i of the best of my knowledge, that all risher and regulation Analis of Chication are truthful and accurate nd that no material fact has been omitted.
S. Ce.
Date: 12 / 3 / 07
or of Quality and Regulatory Affairs 1 Mosteller R. nnati, OH 45
Image /page/1/Picture/18 description: The image is a logo for "WBENC Women's Business Enterprise". The logo is in a black rectangular box with rounded corners. The words "Certified" and "Women's Business Enterprise" are written in a smaller font above and below the large letters "WBENC".
2
Image /page/2/Picture/1 description: The image contains the words "Public Health Service" in a simple, bold, sans-serif font. The text is arranged on a single line, with each word clearly legible. The overall impression is clean and straightforward, suggesting an official or institutional context.
Image /page/2/Picture/2 description: The image shows the seal of the Department of Health and Human Services (HHS) of the United States. The seal features a stylized eagle with three stripes forming its wing, symbolizing health, services, and people. The text "DEPARTMENT OF HEALTH AND HUMAN SERVICES USA" is arranged around the seal's perimeter.
DEC 1 3 2007
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. Fatma Ali Director of Quality & Regulatory Affairs Cincinnati Sub-Zero Products, Incorporated 12011 Mosteller Road Cincinnati, Ohio 45241
Re: K072621
Trade/Device Name: Esophageal/Rectal Temperature Probe and Esophageal Stethoscope with Temperature Sensor Regulation Number: 21 CFR 868.1920 Regulation Name: Esophageal Stethoscope with Electrical Conductors Regulatory Class: II Product Code: BZT Dated: December 4, 2007 Received: December 6, 2007
Dear Ms. Ali:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
3
Page 2 - Ms. Ali
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801). please contact the Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Chiu Liu, Ph.D.
Chiu Lin, Ph.D. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use
10(k) Number (if known):
Unknown
Device Name(s):
rsophageal/Rectal Temperature Probe, Catalog Numbers 483M-9, 483M-12, and 491B
Essophageal Stethoscope with Temperature Sensor, Catalog Numbers 493M-9, 493M-12, 493M-18, and 493M-24
Indications for Use:
Esophageal/Rectal Temperature Probe, Catalog Numbers 483M-9, 483M-12, and 491B: The CSZ sesphageal/rectal temperature probe is intended for use in routine continuous monitoring of the esophageal or medal temperature as an indicator or core body temperature. The probe is designed for placement in the esophagus or rectum.
Boohageal Stethoscope with Temperature Sensor, Catalog Numbers 493M-9, 493M-12, 493M-18, and 493M-24: The CSZ esophageal stethoscope with temperature sensor is intended for use when the esophageal caperature is continuously monitored along with the auscultation of the heart and lung sound as an indicator of core body temperature and cardio-pulmonary performance.
Prescription Use:
and/or
Over-the-Counter Use:
(Part 21CFR801 Subpart D)
XXXXX
(Part 21CFR801 Subpart C)
Arin Bern
(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices
510(k) Number: __ & 47363
Confidential
9/5/2007